LET for Fibromyalgia
Not yet recruitingNot applicableNCT07201818
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
The study is a double blinded, randomized, sham-controlled, parallel group trial conducted at UT Southwestern (UTSW) Medical Center. The purpose of this research study is to determine the effectiveness of Lymphatic Enhancement Technology (LET) treatment in patients with fibromyalgia. Participants will complete assessments of heart rate and blood pressure, pain thresholds to mechanical stimuli, and completion of quality-of-life surveys. In addition, participants will receive four treatments, one time per week, with either an active or sham LET device. Each visit will take between 45 minutes to 2 hours. A follow-up phone call or email from the study team will occur at 4 weeks after completion of the LET treatment. Total study duration is two months.
Study details
- Official title
- A Randomized Sham-Controlled Trial of Lymphatic Enhancement Technology in the Treatment of Fibromyalgia
- Conditions
- Interventions
- Device: Lymphatic Enhancement Technology (LET)
- Device: Sham Lymphatic Enhancement Technology (LET)
- Sponsor
- University of Texas Southwestern Medical Center
- Collaborators
- Arcturus Star Products
- Start date
- 2026-06
- Primary completion
- 2027-10
- Sex
- Female
- Age range
- from 18 Years to 65 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * meeting the American College of Rheumatology 2016 diagnostic criteria for fibromyalgia, * female sex, * ages 18-65 years, * never received LET treatment, * an FIQ score ≥39 (moderate severity), and * no medication changes within 14 days prior to the start of the study or for the duration of the study. Exclusion Criteria: * currently receiving any other form of mind-body or exercise treatment, * active blood clots, * unexplained calf pain with concern for DVT, * active infection, * congestive heart failure, * presence of an implanted pacemaker, * pregnant or may be pregnant, * active cancer or receiving cancer treatment, and * having received any steroid injections within past 3 months.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07201818